Menu
Recruiting NCT04510129

A Multicenter Cancer Biospecimen Collection Study

— Observational Cancer of Head and Neck Lung Cancer, Nonsmall Cell Small-cell Lung Cancer Urothelial Carcinoma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: OncoPrism™ assay.
Who it may be relevant to
Registry conditions: Cancer of Head and Neck, Lung Cancer, Nonsmall Cell, Small-cell Lung Cancer, Urothelial Carcinoma. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Predicting Immunotherapy Efficacy from Analysis of Pre-treatment Tumor Biopsies

Overview

This study will collect de-identified tumor samples, with correlated clinical/demographic data and tissue histology, from patients selected or scheduled for pre-treatment tumor biopsy or who have had a recent pre-treatment tumor biopsy. These specimens and clinical data may be used in subsequent studies for the development and validation of a diagnostic test.

Detailed description

This study will establish a prospective cohort of pre-treatment tumor specimens with correlated de-identified clinical and demographic data and tissue histology from cancer patients who are undergoing treatment with PD-1/PD-L1 inhibitors. Patients who have undergone pre-anti-PD-1/PD-L1-treatment tumor biopsy or who are scheduled for tumor biopsy prior to anti-PD-1/PD-L1 treatment will be enrolled.

The study will not require a study-specific tumor biopsy; any biopsies taken prior to treatment as part of standard of care are eligible for this study. Biopsies must not have been taken after immunotherapy treatment began.

Participants will be asked to provide their consent for the potential use of their biospecimens in subsequent studies for the development and validation of a diagnostic test.

Interventions

  • Diagnostic test OncoPrism™ assay
    OncoPrism™ is a new approach to characterizing the immune component of pre-treatment tumor tissue.

Primary outcome measures

  • PD-L1/PD-1 inhibitor response [Time frame: 6 months]

Eligibility criteria

Inclusion criteria

  • Subject must have a disease of interest. Specifically, subject must have one of:
  • head and neck squamous cell carcinoma (HNSCC)
  • non-small-cell lung cancer (NSCLC)
  • small cell lung cancer (SCLC)
  • urothelial carcinoma (UCC)
  • gastric or gastroesophageal junction adenocarcinoma
  • cervical cancer
  • esophageal squamous cell carcinoma (ESCC)
  • triple-negative breast cancer (TNBC)
  • hepatocellular carcinoma (HCC)
  • renal cell carcinoma (RCC)
  • colorectal cancer (CRC)
  • Subject must have received, or be scheduled to receive, at least one dose of anti-PD-1/PD-L1 immunotherapy for treatment of their cancer.
  • Subject must have had, or will have, a tumor biopsy prior to treatment with anti-PD-1/PD-L1 immunotherapy.
  • Subject must have undergone, or will undergo, medical imaging (e.g. CT or MRI) of the tumor prior to treatment with anti-PD-1/PD-L1 immunotherapy.
  • Willing to provide electronic informed consent per IRB-approved protocol.
  • Able to speak, read, and comprehend English fluently.
  • Subject is 18 years of age or older.
  • Subjects must have sufficient tissue available to fulfill the specimen requirements of the study.

Exclusion criteria

  • Inability or unwillingness to provide informed consent.
  • Subject who does/did not have one of the cancers listed above (other histologies).
  • Subject has already participated in this trial.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-only

Study locations

United States · 1 center
  • Curebase — San Francisco

Publications

  • Flanagan KC, Earls J, Hiken J, Wellinghoff RL, Ponder MM, McLeod HL, Westra WH, Vavinskaya V, Sutton L, Deichaite I, Macdonald OK, Welaya K, Wade J 3rd, Azzi G, Pippas AW, Slim J, Bank B, Sui X, Kossman SE, Shenkenberg TD, Alexander WL, Price KA, Ley J, Messina DN, Glasscock JI, Colevas AD, Cohen EEW, Adkins D, Duncavage EJ. Multicenter validation of an RNA-based assay to predict anti-PD-1 disease PMID 39489541

Identifiers

NCT: NCT04510129 · PREDAPT

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗